Pathogen-focused Clinical Development to Address Unmet Medical Need: Cefiderocol Targeting Carbapenem Resistance

Clinical Infectious Diseases

Volumn 69, Issue , 2019, Pages S559-S564

  Echols, Roger ^a   Ariyasu, Mari ^b   Nagata, Tsutae Den ^b  

^a Infectious Disease Drug Development Consulting LLC   (United States)

^b SHIONOGI AND CO LTD   (Japan)

Author keywords

carbapenem resistance; cefiderocol; nonfermenters; pathogen focused drug development; regulatory drug approval

Indexed keywords

CARBAPENEM; CEFIDEROCOL; ANTIINFECTIVE AGENT; CARBAPENEM DERIVATIVE; CEPHALOSPORIN DERIVATIVE;

ACINETOBACTER INFECTION; ARTICLE; BACTERIAL PNEUMONIA; BLOODSTREAM INFECTION; CARBAPENEM RESISTANCE; DRUG APPROVAL; DRUG INDICATION; DRUG SYNTHESIS; ESCHERICHIA COLI INFECTION; FOOD AND DRUG ADMINISTRATION; HOSPITAL INFECTION; HUMAN; INFECTIOUS AGENT; KLEBSIELLA INFECTION; PRIORITY JOURNAL; PSEUDOMONAS INFECTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); STENOTROPHOMONAS; UNITED STATES; URINARY TRACT INFECTION; ANTIBIOTIC RESISTANCE; CLINICAL TRIAL (TOPIC); EUROPE;

ANTI-BACTERIAL AGENTS; CARBAPENEMS; CEPHALOSPORINS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG RESISTANCE, BACTERIAL; EUROPE; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85075035267     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/ciz829     Document Type: Article

References (24)

1. Cai B, Echols R, Magee G, et al. Prevalence of carbapenem-resistant gram-negative infections in the United States predominated by Acinetobacter baumannii and Pseudomonas aeruginosa. Open Forum Infect Dis 2017; 4:ofx176.
2. Nordmann P, Poirel L. Epidemiology and diagnostics of carbapenem resistance in gram-negative bacteria. Clin Infect Dis 2019; 69(Suppl 7):521-8.
3. European Centre for Disease Prevention and Control. Surveillance of antimicrobial resistance in Europe-annual report of the European Antimicrobial Resistance Surveillance Network (EARS-Net), 2017. Available at: https://ecdc.europa. eu/sites/portal/files/documents/EARS-Net-report-2017-update-jan-2019. pdf. Accessed 3 March 2019.
4. World Health Organization. Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. 2017. Available at: http://www.who.int/medicines/publications/WHO-PPL-Short-Summary-25Feb-ET-NM-WHO.pdf. Accessed 1 February 2019.
5. Aoki T, Yoshizawa H, Yamawaki K, et al. Cefiderocol (S-649266), a new siderophore cephalosporin exhibiting potent activities against Pseudomonas aeruginosa and other gram-negative pathogens including multi-drug resistant bacteria: structure activity relationship. Eur J Med Chem 2018; 155:847-68.
6. Echols RM. A long and winding road; evolution of antimicrobial drug development-crisis management. Expert Rev Anti Infect Ther 2012; 10:1311-9.
7. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for industry, expedited programs for serious conditions-drugs and biologics. 2014. Available at: https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf. Accessed 3 March 2019.
8. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Draft guidance for industry on antibacterial therapies for patients with unmet medical need for the treatment of serious bacterial diseases. 2013. Available at: https://www.govinfo.gov/content/pkg/FR-2013-07-02/pdf/2013-15783.pdf. Accessed 3 March 2019.
9. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Unmet medical need for the treatment of serious bacterial diseases. Guidance for industry. 2017. Available at: https://www.govinfo.gov/content/pkg/FR-2017-08-02/pdf/2017-16228.pdf. Accessed 3 March 2019.
10. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases. 2017. Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM359184. pdf. Accessed 3 March 2019.
11. US Food and Drug Administration. Briefing document. Developing antibacterial therapies targeting a single bacterial species meeting of the Antimicrobial Drugs Advisory Committee (AMDAC). 2017. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM551632.pdf. Accessed 6 March 2019.
12. European Medicines Agency Committee for Medicinal Products for Human Use. Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. EMA/CHMP/351889/2013; page 16, paragraph ii. London: EMA, 2013.
13. Portsmouth S, van Veenhuyzen D, Echols R, et al. Cefiderocol versus imipenemcilastatin for the treatment of complicated urinary tract infections caused by gram-negative uropathogens: a phase 2, randomised, double-blind, noninferiority trial. Lancet Infect Dis 2018; 18:1319-28.
14. A study of efficacy/safety of intravenous S-649266 versus imipenem/cilastatin in complicated urinary tract infections (APEKS-cUTI). Available at: https://clinicaltrials.gov/ct2/show/NCT02321800. Accessed 4 March 2019.
15. Bass A, Echols R, Portsmouth S, Howell A. Heterogeneity of recent phase 3 cUTI clinical trials with new antibiotics. Open Forum Infect Dis 2018; 5(Suppl 1):S472.
16. Study of S-649266 or best available therapy for the treatment of severe infections caused by carbapenem-resistant gram-negative pathogens (CREDIBLE-CR). Available at: https://clinicaltrials.gov/ct2/show/NCT02714595. Accessed 4 March 2019.
17. Clinical study of S-649266 for the treatment of nosocomial pneumonia caused by gram-negative pathogens (APEKS-NP). Available at: https://clinicaltrials.gov/ct2/show/NCT03032380. Accessed 4 March 2019.
18. Yamano Y. In vitro activity of cefiderocol against a broad range of clinically important gram-negative bacteria. Clin Infect Dis 2019; 69(Suppl 7):544-51.
19. Ito A, Sato T, Ota M, et al. In vitro antibacterial properties of cefiderocol, a novel siderophore cephalosporin, against gram-negative bacteria. Antimicrob Agents Chemother 2017; 62:e01454-17.
20. Sato T, Yamawaki K. Cefiderocol: discovery, chemistry, and in vivo profiles of a novel siderophore cephalosporin. Clin Infect Dis 2019; 69(Suppl 7):538-43.
21. Humphries RM, Hindler JA. Emerging resistance, new antimicrobial agents ... but no tests! the challenge of antimicrobial susceptibility testing in the current US regulatory landscape. Clin Infect Dis 2016; 63:83-8.
22. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Systemic antibacterial and antifungal drugs. Susceptibility test interpretive criteria labeling for NDAs and ANDAs guidance for industry. 2017. Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588747.pdf. Accessed 3 March 2019.
23. Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing, 29th informational supplement. CLSI supplement M100. Wayne, PA: CLSI, 2019.
24. US Food and Drug Administration. Antibacterial susceptibility test interpretive criteria. Available at: https://www.fda.gov/drugs/development-resources/antibacterial-susceptibility-test-interpretive-criteria. Accessed 2 September 2019.